Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
74761–74784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2002
EMS 400
K022493 · IPF
Body Clock Health Care, Ltd.
Physical Medicine · 74d
Cleared Oct 11, 2002
GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020
K022545 · NBW
Hypoguard USA, Inc.
Chemistry · 71d
Cleared Oct 11, 2002
VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION
K022562 · DZE
Nobel Biocare AB
Dental · 70d
Cleared Oct 11, 2002
KIMAX QMA
K022585 · LLZ
Medical Metrics, Inc.
Radiology · 67d
Cleared Oct 11, 2002
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND...
K022620 · FKA
Spire Biomedical, Inc.
Gastroenterology & Urology · 65d
Cleared Oct 11, 2002
VOXELPLUS PACS
K022692 · LLZ
Mevisys Co., Ltd.
Radiology · 59d
Cleared Oct 11, 2002
SMARTPACS
K022710 · LLZ
Taiwan Electronic Data Processing...
Radiology · 58d
Cleared Oct 11, 2002
MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB
K022716 · HNO
Med-Logics, Inc.
Ophthalmic · 57d
Cleared Oct 11, 2002
AUDIOTRAVELLER, MODEL AA222
K022728 · ETY
Interacoustics A/S, Assens
Ear, Nose, Throat · 56d
Cleared Oct 11, 2002
SPIFE CK KIT, MODEL 3332, 3333
K022757 · JHY
Helena Laboratories
Chemistry · 52d
Cleared Oct 11, 2002
NITRILE POWDER-FREE EXAMINATION GLOVES
K022765 · LZA
Allegiance Healthcare Corp.
General Hospital · 52d
Cleared Oct 11, 2002
E-SPEED EBT SCANNER SYSTEM
K022794 · JAK
Ge Imatron
Radiology · 49d
Cleared Oct 11, 2002
COBRASCAN CR-1 FILMLESS
K022810 · LMA
Radiographic Digital Imaging, Inc.
Radiology · 49d
Cleared Oct 11, 2002
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K022897 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 38d
Cleared Oct 11, 2002
IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0
K022940 · LLZ
Intelligent Images Srl
Radiology · 37d
Cleared Oct 11, 2002
ACUITY RADIATION THERAPY SIMULATOR
K023052 · KPQ
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Oct 11, 2002
KONICA DIRECT DIGITIZER REGIUS, MODEL 170
K023061 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 25d
Cleared Oct 11, 2002
ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS
K023100 · LLZ
General Electric Medical Systems...
Radiology · 23d
Cleared Oct 11, 2002
ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM
K023130 · LNH
Mri Devices Corp.
Radiology · 21d
Cleared Oct 11, 2002
VINYL EXAMINATION GLOVES, PRE-POWDERED
K023145 · LYZ
Shandong Jiazhan Plastic Products...
General Hospital · 21d
Cleared Oct 11, 2002
BBC-63-GE BREAST ARRAY COIL
K023164 · MOS
Mri Devices Corp.
Radiology · 18d
Cleared Oct 11, 2002
CONTACT LASER & DIAGNOSTIC LENSES
K023221 · HJK
Volk Optical, Inc.
Ophthalmic · 14d
Cleared Oct 10, 2002
AART SILICONE TUBING
K022306 · KGZ
Aesthetic and Reconstructive...
General & Plastic Surgery · 86d
Cleared Oct 10, 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K022316 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 85d